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Sanofi/Regeneron's aflibercept fails trial

Thursday, March 17, 2011 01:06 PM

Sanofi-aventis and partner Regeneron have suffered a setback with their investigational agent aflibercept failing a late-stage trial for non-small cell lung cancer (NSCLC), according to PharmaTimes.

Top-line data from the 913-patient phase III VITAL trial evaluating aflibercept (also known as VEGF Trap) for the second-line treatment of NSCLC showed that adding the drug to the chemotherapy docetaxel did not meet the primary endpoint of improvement in overall survival compared with docetaxel plus placebo. However, the addition of aflibercept to docetaxel demonstrated activity as measured by secondary endpoints, i.e., progression-free survival and an overall objective response rate (ORR) of 23.3% in the aflibercept arm compared to 8.9% for the placebo/chemotherapy combo.

The companies said they will conduct a detailed analysis of the efficacy and safety results of VITAL and present full results at an upcoming medical meeting.

Debasish Roychowdhury, head of oncology at Sanofi, said, "bringing new and innovative cancer therapies to patients can be incredibly challenging, especially in difficult-to-treat cancers such as second-line NSCLC.”

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